Stivarga therapy provided clinical benefit to patients with hepatocellular carcinoma and had similar adverse event rates regardless of the last Nexavar dose or time-to-progression on prior Nexavar therapy, according to a recently published study.
Richard S. Finn, MD, from the David Geffen School of Medicine at the University of California Los Angeles, and colleagues conducted a retrospective analysis of the RESOURCE trial — the results of which showed Stivarga (regorafenib, Bayer) significantly improved overall survival in patients whose HCC progressed during Nexavar (sorafenib, Bayer) therapy — to verify the outcomes of sequential treatment with sorafenib followed by regorafenib.
In the RESOURCE trial, researchers randomly assigned 379 patients to receive regorafenib and 194 patients to receive placebo. Demographic and disease characteristics and use of prior local therapies were balanced between the two groups. At baseline, median time from the start of sorafenib therapy to HCC progression was 7.2 months for the group receiving regorafenib and 7.1 months for the group receiving placebo.
At the end of the study, overall survival rates were significantly better among the regorafenib group compared with the placebo group (10.6 vs. 7.8 months; HR = 0.62; 95% CI, 0.5-0.78). The researchers conducted a secondary analysis nearly 1 year after the primary analysis and found similar results (10.7 vs. 7.9 months; HR = 0.61; 95% CI, 0.5-0.75).
Subgroup analysis of patients who received 800 mg per day of regorafenib and those who received less than 800 mg per day showed similar overall survival rates.
Regorafenib showed significantly consistent time-to-progression benefit over placebo regardless of time-to-progression on prior sorafenib.
“The safety profile of regorafenib was generally consistent with that reported for regorafenib in other gastrointestinal malignancies, and rates of adverse events were generally similar when analyzed by the last sorafenib dose,” Finn and colleagues wrote. “The results presented here suggest that for certain patients with HCC who no longer benefit from resection, local ablation, or chemoembolization, treatment with the sequence of sorafenib followed by regorafenib may extend survival beyond what has been previously reported.” – by Talitha Bennett
Disclosure: Finn reports he received consultant fees from Bayer, Bristol-Myers Squibb, Eisai, Merck, Pfizer, Roche and Lilly. Please see the full study for the other authors’ relevant financial disclosures.